Bioequivalence of Implanon® and Radiopaque Implanon. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Bioequivalence testing was performed based on serum etonogestrel AUC0-6months, AUC0-24months, and AUC0-36months. Bioequivalence was to be concluded when the 90% confidence limits of AUC0-6months, AUC0-24months, and AUC0-36months were fully contained within the acceptance range of 0.80-1.25.

AUC0-6months (Area under the curve from zero to six months).

AUC0-24months (Area under the curve from zero to 24 months).

AUC0-36months (Area under the curve from zero to 36 months).

Bioequivalence of Implanon® and Radiopaque Implanon [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Bioequivalence testing was performed based on serum etonogestrel Cmax. Bioequivalence was to be concluded when the 90% confidence limits of Cmax were fully contained within the acceptance range of 0.80-1.25.

Present use or use during 2 months prior to the start of Implanon/Radiopaque Implanon of one of the following drugs: phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin or the herbal remedy St John's wort.

Administration of investigational drugs within 2 months prior to the start of Implanon/Radiopaque Implanon

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